Releasable tissue anchoring device, methods for using, and methods for making

ABSTRACT

Embodiments of invention are directed to tissue approximation instruments that may be delivered to the body of a patient during minimally invasive or other surgical procedures. In one group of embodiments, the instruments have an elongated configuration with two sets of expandable wings that each have spreadable wings that can be made to expand when located on opposite sides of a distal tissue region and a proximal tissue region and can then be made to move toward one another to bring the two tissue regions into a more proximate position. The instrument is delivered through a needle or catheter and is controlled by relative movement of a push tube and control wire wherein the control wire can be released from the instrument via rotation in a first direction and can cause release of the approximation device from tissue that it is holding by rotation in the opposite direction.

RELATED APPLICATIONS

This application claims the benefit of U.S. Prov. Pat. App. No.61/142,149 filed Dec. 31, 2008 and is also a continuation in part (CIP)of U.S. patent application Ser. No. 12/346,034, filed Dec. 30, 2008 nowabandoned The '034 application in turn claims benefit to U.S. Prov. App.61/018,269, filed Dec. 31, 2007; and is a CIP of U.S. application Ser.No. 11/591,911, filed Nov. 1, 2006 now abandoned, a CIP of U.S.application Ser. No. 11/598,968, filed Nov. 14, 2006 now abandoned, anda CIP of U.S. application Ser. No. 11/625,807, filed Jan. 22, 2007 nowabandoned. The '911 app. claims benefit of U.S. Prov. App. Nos.60/732,413, filed Nov. 1, 2005; 60/736,961, filed Nov. 14, 2005, and60/761,401, filed Jan. 20, 2006; the '968 application claims benefit ofU.S. Prov. App. Nos. 60/736,961, filed Nov. 14, 2005, and 60/761,401,filed Jan. 20, 2006, and is a CIP of U.S. application Ser. No.11/591,911, filed Nov. 1, 2006. The '807 app. claims benefit of U.S.Prov. App. No. 60/761,401, filed Jan. 20, 2006, and is a CIP of U.S.application Ser. No. 11/598,968, filed Nov. 14, 2006 now abandoned, Ser.No. 11/582,049, filed Oct. 16, 2006, now U.S. Pat. No. 7,686,770 issuedon Mar. 30, 2010, Ser. No. 11/444,999, filed May 31, 2006 now abandoned,and Ser. No. 10/697,598, filed Oct. 29, 2003 now abandoned. The '049app. claims the benefit to U.S. Prov. App. No. 60/726,794, filed Oct.14, 2005; the '999 app. claims benefit of U.S. Prov. App. No.60/686,496, filed May 31, 2005 and is a CIP of U.S. application Ser. No.10/697,598, filed Oct. 29, 2003 now abandoned. The '598 app. claimsbenefit of U.S. Prov. App. No. 60/422,007, filed Oct. 29, 2002. Each ofthese applications is hereby incorporated herein by reference as if setforth in full herein.

U.S. GOVERNMENT RIGHTS

At least a portion of the inventions disclosed and claimed herein weremade with government support under Grant No. R01 HL087797 awarded by theNational Institutes of Health. The Government has certain rights inthese inventions.

FIELD OF THE INVENTION

The present invention relates to medical devices or instruments and inparticular to medical devices that can be used for tissue approximationand retention/fixation that may be implemented in a surgical procedure(e.g. a minimally invasive surgical procedure). In some embodiments amicroscale or millimeter scale working portion of the device orinstrument may be formed using a multilayer, multi-material fabricationprocess.

BACKGROUND OF THE INVENTION

Electrochemical Fabrication:

An electrochemical fabrication technique for forming three-dimensionalstructures from a plurality of adhered layers is being commerciallypursued by Microfabrica® Inc. (formerly MEMGen Corporation) of Van Nuys,Calif. under the name EFAB®.

Various electrochemical fabrication techniques were described in U.S.Pat. No. 6,027,630, issued on Feb. 22, 2000 to Adam Cohen. Someembodiments of this electrochemical fabrication technique allow theselective deposition of a material using a mask that includes apatterned conformable material on a support structure that isindependent of the substrate onto which plating will occur. Whendesiring to perform an electrodeposition using the mask, the conformableportion of the mask is brought into contact with a substrate, but notadhered or bonded to the substrate, while in the presence of a platingsolution such that the contact of the conformable portion of the mask tothe substrate inhibits deposition at selected locations. Forconvenience, these masks might be generically called conformable contactmasks; the masking technique may be generically called a conformablecontact mask plating process. More specifically, in the terminology ofMicrofabrica Inc. such masks have come to be known as INSTANT MASKS™ andthe process known as INSTANT MASKING™ or INSTANT MASK™ plating.Selective depositions using conformable contact mask plating may be usedto form single selective deposits of material or may be used in aprocess to form multi-layer structures. The teachings of the '630 patentare hereby incorporated herein by reference as if set forth in fullherein. Since the filing of the patent application that led to the abovenoted patent, various papers about conformable contact mask plating(i.e. INSTANT MASKING) and electrochemical fabrication have beenpublished:

-   -   (1) A. Cohen, G. Zhang, F. Tseng, F. Mansfeld, U. Frodis and P.        Will, “EFAB: Batch production of functional, fully-dense metal        parts with micro-scale features”, Proc. 9th Solid Freeform        Fabrication, The University of Texas at Austin, p 161, August        1998.    -   (2) A. Cohen, G. Zhang, F. Tseng, F. Mansfeld, U. Frodis and P.        Will, “EFAB: Rapid, Low-Cost Desktop Micromachining of High        Aspect Ratio True 3-D MEMS”, Proc. 12th IEEE Micro Electro        Mechanical Systems Workshop, IEEE, p 244, January 1999.    -   (3) A. Cohen, “3-D Micromachining by Electrochemical        Fabrication”, Micromachine Devices, March 1999.    -   (4) G. Zhang, A. Cohen, U. Frodis, F. Tseng, F. Mansfeld, and P.        Will, “EFAB: Rapid Desktop Manufacturing of True 3-D        Microstructures”, Proc. 2nd International Conference on        Integrated MicroNanotechnology for Space Applications, The        Aerospace Co., April 1999.    -   (5) F. Tseng, U. Frodis, G. Zhang, A. Cohen, F. Mansfeld, and P.        Will, “EFAB: High Aspect Ratio, Arbitrary 3-D Metal        Microstructures using a Low-Cost Automated Batch Process”, 3rd        International Workshop on High Aspect Ratio MicroStructure        Technology (HARMST'99), June 1999.    -   (6) A. Cohen, U. Frodis, F. Tseng, G. Zhang, F. Mansfeld, and P.        Will, “EFAB: Low-Cost, Automated Electrochemical Batch        Fabrication of Arbitrary 3-D Microstructures”, Micromachining        and Microfabrication Process Technology, SPIE 1999 Symposium on        Micromachining and Microfabrication, September 1999.    -   (7) F. Tseng, G. Zhang, U. Frodis, A. Cohen, F. Mansfeld, and P.        Will, “EFAB: High Aspect Ratio, Arbitrary 3-D Metal        Microstructures using a Low-Cost Automated Batch Process”, MEMS        Symposium, ASME 1999 International Mechanical Engineering        Congress and Exposition, November, 1999.    -   (8) A. Cohen, “Electrochemical Fabrication (EFABTM)”, Chapter 19        of The MEMS Handbook, edited by Mohamed Gad-El-Hak, CRC Press,        2002.    -   (9) Microfabrication—Rapid Prototyping's Killer Application”,        pages 1-5 of the Rapid Prototyping Report, CAD/CAM Publishing,        Inc., June 1999.

The disclosures of these nine publications are hereby incorporatedherein by reference as if set forth in full herein.

An electrochemical deposition for forming multilayer structures may becarried out in a number of different ways as set forth in the abovepatent and publications. In one form, this process involves theexecution of three separate operations during the formation of eachlayer of the structure that is to be formed:

-   -   1. Selectively depositing at least one material by        electrodeposition upon one or more desired regions of a        substrate. Typically this material is either a structural        material or a sacrificial material.    -   2. Then, blanket depositing at least one additional material by        electrodeposition so that the additional deposit covers both the        regions that were previously selectively deposited onto, and the        regions of the substrate that did not receive any previously        applied selective depositions. Typically this material is the        other of a structural material or a sacrificial material.    -   3. Finally, planarizing the materials deposited during the first        and second operations to produce a smoothed surface of a first        layer of desired thickness having at least one region containing        the at least one material and at least one region containing at        least the one additional material.

After formation of the first layer, one or more additional layers may beformed adjacent to an immediately preceding layer and adhered to thesmoothed surface of that preceding layer. These additional layers areformed by repeating the first through third operations one or more timeswherein the formation of each subsequent layer treats the previouslyformed layers and the initial substrate as a new and thickeningsubstrate.

Once the formation of all layers has been completed, at least a portionof at least one of the materials deposited is generally removed by anetching process to expose or release the three-dimensional structurethat was intended to be formed. The removed material is a sacrificialmaterial while the material that forms part of the desired structure isa structural material.

The preferred method of performing the selective electrodepositioninvolved in the first operation is by conformable contact mask plating.In this type of plating, one or more conformable contact (CC) masks arefirst formed. The CC masks include a support structure onto which apatterned conformable dielectric material is adhered or formed. Theconformable material for each mask is shaped in accordance with aparticular cross-section of material to be plated (the pattern ofconformable material is complementary to the pattern of material to bedeposited). At least one CC mask is used for each unique cross-sectionalpattern that is to be plated.

The support for a CC mask is typically a plate-like structure formed ofa metal that is to be selectively electroplated and from which materialto be plated will be dissolved. In this typical approach, the supportwill act as an anode in an electroplating process. In an alternativeapproach, the support may instead be a porous or otherwise perforatedmaterial through which deposition material will pass during anelectroplating operation on its way from a distal anode to a depositionsurface. In either approach, it is possible for multiple CC masks toshare a common support, i.e. the patterns of conformable dielectricmaterial for plating multiple layers of material may be located indifferent areas of a single support structure. When a single supportstructure contains multiple plating patterns, the entire structure isreferred to as the CC mask while the individual plating masks may bereferred to as “submasks”. In the present application such a distinctionwill be made only when relevant to a specific point being made.

In preparation for performing the selective deposition of the firstoperation, the conformable portion of the CC mask is placed inregistration with and pressed against a selected portion of (1) thesubstrate, (2) a previously formed layer, or (3) a previously depositedportion of a layer on which deposition is to occur. The pressingtogether of the CC mask and relevant substrate occur in such a way thatall openings, in the conformable portions of the CC mask contain platingsolution. The conformable material of the CC mask that contacts thesubstrate acts as a barrier to electrodeposition while the openings inthe CC mask that are filled with electroplating solution act as pathwaysfor transferring material from an anode (e.g. the CC mask support) tothe non-contacted portions of the substrate (which act as a cathodeduring the plating operation) when an appropriate potential and/orcurrent are supplied.

An example of a CC mask and CC mask plating are shown in FIGS. 1A-1C.FIG. 1A shows a side view of a CC mask 8 consisting of a conformable ordeformable (e.g. elastomeric) insulator 10 patterned on an anode 12. Theanode has two functions. One is as a supporting material for thepatterned insulator 10 to maintain its integrity and alignment since thepattern may be topologically complex (e.g., involving isolated “islands”of insulator material). The other function is as an anode for theelectroplating operation. FIG. 1A also depicts a substrate 6, separatedfrom mask 8, onto which material will be deposited during the process offorming a layer. CC mask plating selectively deposits material 22 ontosubstrate 6 by simply pressing the insulator against the substrate thenelectrodepositing material through apertures 26 a and 26 b in theinsulator as shown in FIG. 1B. After deposition, the CC mask isseparated, preferably non-destructively, from the substrate 6 as shownin FIG. 1C.

The CC mask plating process is distinct from a “through-mask” platingprocess in that in a through-mask plating process the separation of themasking material from the substrate would occur destructively.Furthermore in a through mask plating process, opening in the maskingmaterial are typically formed while the masking material is in contactwith and adhered to the substrate. As with through-mask plating, CC maskplating deposits material selectively and simultaneously over the entirelayer. The plated region may consist of one or more isolated platingregions where these isolated plating regions may belong to a singlestructure that is being formed or may belong to multiple structures thatare being formed simultaneously. In CC mask plating as individual masksare not intentionally destroyed in the removal process, they may beusable in multiple plating operations.

Another example of a CC mask and CC mask plating is shown in FIGS.1D-1G. FIG. 1D shows an anode 12′ separated from a mask 8′ that includesa patterned conformable material 10′ and a support structure 20. FIG. 1Dalso depicts substrate 6 separated from the mask 8′. FIG. 1E illustratesthe mask 8′ being brought into contact with the substrate 6. FIG. 1Fillustrates the deposit 22′ that results from conducting a current fromthe anode 12′ to the substrate 6. FIG. 1G illustrates the deposit 22′ onsubstrate 6 after separation from mask 8′. In this example, anappropriate electrolyte is located between the substrate 6 and the anode12′ and a current of ions coming from one or both of the solution andthe anode are conducted through the opening in the mask to the substratewhere material is deposited. This type of mask may be referred to as ananodeless INSTANT MASK™ (AIM) or as an anodeless conformable contact(ACC) mask.

Unlike through-mask plating, CC mask plating allows CC masks to beformed completely separate from the substrate on which plating is tooccur (e.g. separate from a three-dimensional (3D) structure that isbeing formed). CC masks may be formed in a variety of ways, for example,using a photolithographic process. All masks can be generatedsimultaneously, e.g. prior to structure fabrication rather than duringit. This separation makes possible a simple, low-cost, automated,self-contained, and internally-clean “desktop factory” that can beinstalled almost anywhere to fabricate 3D structures, leaving anyrequired clean room processes, such as photolithography to be performedby service bureaus or the like.

An example of the electrochemical fabrication process discussed above isillustrated in FIGS. 2A-2F. These figures show that the process involvesdeposition of a first material 2 which is a sacrificial material and asecond material 4 which is a structural material. The CC mask 8, in thisexample, includes a patterned conformable material (e.g. an elastomericdielectric material) 10 and a support 12 which is made from depositionmaterial 2. The conformal portion of the CC mask is pressed againstsubstrate 6 with a plating solution 14 located within the openings 16 inthe conformable material 10. An electric current, from power supply 18,is then passed through the plating solution 14 via (a) support 12 whichdoubles as an anode and (b) substrate 6 which doubles as a cathode. FIG.2A illustrates that the passing of current causes material 2 within theplating solution and material 2 from the anode 12 to be selectivelytransferred to and plated on the substrate 6. After electroplating thefirst deposition material 2 onto the substrate 6 using CC mask 8, the CCmask 8 is removed as shown in FIG. 2B. FIG. 2C depicts the seconddeposition material 4 as having been blanket-deposited (i.e.non-selectively deposited) over the previously deposited firstdeposition material 2 as well as over the other portions of thesubstrate 6. The blanket deposition occurs by electroplating from ananode (not shown), composed of the second material, through anappropriate plating solution (not shown), and to the cathode/substrate6. The entire two-material layer is then planarized to achieve precisethickness and flatness as shown in FIG. 2D. After repetition of thisprocess for all layers, the multi-layer structure 20 formed of thesecond material 4 (i.e. structural material) is embedded in firstmaterial 2 (i.e. sacrificial material) as shown in FIG. 2E. The embeddedstructure is etched to yield the desired device, i.e. structure 20, asshown in FIG. 2F.

Various components of an exemplary manual electrochemical fabricationsystem 32 are shown in FIGS. 3A-3C. The system 32 consists of severalsubsystems 34, 36, 38, and 40. The substrate holding subsystem 34 isdepicted in the upper portions of each of FIGS. 3A-3C and includesseveral components: (1) a carrier 48, (2) a metal substrate 6 onto whichthe layers are deposited, and (3) a linear slide 42 capable of movingthe substrate 6 up and down relative to the carrier 48 in response todrive force from actuator 44. Subsystem 34 also includes an indicator 46for measuring differences in vertical position of the substrate whichmay be used in setting or determining layer thicknesses and/ordeposition thicknesses. The subsystem 34 further includes feet 68 forcarrier 48 which can be precisely mounted on subsystem 36.

The CC mask subsystem 36 shown in the lower portion of FIG. 3A includesseveral components: (1) a CC mask 8 that is actually made up of a numberof CC masks (i.e. submasks) that share a common support/anode 12, (2)precision X-stage 54, (3) precision Y-stage 56, (4) frame 72 on whichthe feet 68 of subsystem 34 can mount, and (5) a tank 58 for containingthe electrolyte 16. Subsystems 34 and 36 also include appropriateelectrical connections (not shown) for connecting to an appropriatepower source (not shown) for driving the CC masking process.

The blanket deposition subsystem 38 is shown in the lower portion ofFIG. 3B and includes several components: (1) an anode 62, (2) anelectrolyte tank 64 for holding plating solution 66, and (3) frame 74 onwhich feet 68 of subsystem 34 may sit. Subsystem 38 also includesappropriate electrical connections (not shown) for connecting the anodeto an appropriate power supply (not shown) for driving the blanketdeposition process.

The planarization subsystem 40 is shown in the lower portion of FIG. 3Cand includes a lapping plate 52 and associated motion and controlsystems (not shown) for planarizing the depositions.

In addition to teaching the use of CC masks for electrodepositionpurposes, the '630 patent also teaches that the CC masks may be placedagainst a substrate with the polarity of the voltage reversed andmaterial may thereby be selectively removed from the substrate. Itindicates that such removal processes can be used to selectively etch,engrave, and polish a substrate, e.g., a plaque.

The '630 patent further indicates that the electroplating methods andarticles disclosed therein allow fabrication of devices from thin layersof materials such as, e.g., metals, polymers, ceramics, andsemiconductor materials. It further indicates that although theelectroplating embodiments described therein have been described withrespect to the use of two metals, a variety of materials, e.g.,polymers, ceramics and semiconductor materials, and any number of metalscan be deposited either by the electroplating methods therein, or inseparate processes that occur throughout the electroplating method. Itindicates that a thin plating base can be deposited, e.g., bysputtering, over a deposit that is insufficiently conductive (e.g., aninsulating layer) so as to enable subsequent electroplating. It alsoindicates that multiple support materials (i.e. sacrificial materials)can be included in the electroplated element allowing selective removalof the support materials.

The '630 patent additionally teaches that the electroplating methodsdisclosed therein can be used to manufacture elements having complexmicrostructure and close tolerances between parts. An example is givenwith the aid of FIGS. 14A-14E of that patent. In the example, elementshaving parts that fit with close tolerances, e.g., having gaps betweenabout 1-5 um, including electroplating the parts of the device in anunassembled, preferably pre-aligned, state and once fabricated. In suchembodiments, the individual parts can be moved into operational relationwith each other or they can simply fall together. Once together theseparate parts may be retained by clips or the like.

Another method for forming microstructures from electroplated metals(i.e. using electrochemical fabrication techniques) is taught in U.S.Pat. No. 5,190,637 to Henry Guckel, entitled “Formation ofMicrostructures by Multiple Level Deep X-ray Lithography withSacrificial Metal layers”. This patent teaches the formation of metalstructure utilizing through mask exposures. A first layer of a primarymetal is electroplated onto an exposed plating base to fill a void in aphotoresist (the photoresist forming a through mask having a desiredpattern of openings), the photoresist is then removed and a secondarymetal is electroplated over the first layer and over the plating base.The exposed surface of the secondary metal is then machined down to aheight which exposes the first metal to produce a flat uniform surfaceextending across both the primary and secondary metals. Formation of asecond layer may then begin by applying a photoresist over the firstlayer and patterning it (i.e. to form a second through mask) and thenrepeating the process that was used to produce the first layer toproduce a second layer of desired configuration. The process is repeateduntil the entire structure is formed and the secondary metal is removedby etching. The photoresist is formed over the plating base or previouslayer by casting and patterning of the photoresist (i.e. voids formed inthe photoresist) are formed by exposure of the photoresist through apatterned mask via X-rays or UV radiation and development of the exposedor unexposed areas.

The '637 patent teaches the locating of a plating base onto a substratein preparation for electroplating materials onto the substrate. Theplating base is indicated as typically involving the use of a sputteredfilm of an adhesive metal, such as chromium or titanium, and then asputtered film of the metal that is to be plated. It is also taught thatthe plating base may be applied over an initial layer of sacrificialmaterial (i.e. a layer or coating of a single material) on the substrateso that the structure and substrate may be detached if desired. In suchcases after formation of the structure the sacrificial material formingpart of each layer of the structure may be removed along the initialsacrificial layer to free the structure. Substrate materials mentionedin the '637 patent include silicon, glass, metals, and silicon withprotected semiconductor devices. A specific example of a plating baseincludes about 150 angstroms of titanium and about 300 angstroms ofnickel, both of which are sputtered at a temperature of 160° C. Inanother example it is indicated that the plating base may consist of 150angstroms of titanium and 150 angstroms of nickel where both are appliedby sputtering.

Electrochemical Fabrication provides the ability to form prototypes andcommercial quantities of miniature objects, parts, structures, devices,and the like at reasonable costs and in reasonable times. In fact,Electrochemical Fabrication is an enabler for the formation of manystructures that were hitherto impossible to produce. ElectrochemicalFabrication opens the spectrum for new designs and products in manyindustrial fields. Even though Electrochemical Fabrication offers thisnew capability and it is understood that Electrochemical Fabricationtechniques can be combined with designs and structures known withinvarious fields to produce new structures, certain uses forElectrochemical Fabrication provide designs, structures, capabilitiesand/or features not known or obvious in view of the state of the art.

A need exists in various fields for miniature devices having improvedcharacteristics, reduced fabrication times, reduced fabrication costs,simplified fabrication processes, greater versatility in device design,improved selection of materials, improved material properties, more costeffective and less risky production of such devices, and/or moreindependence between geometric configuration and the selectedfabrication process.

SUMMARY OF THE INVENTION

It is an object of some embodiments of the invention to provide animproved tissue approximation device that is readily removable.

It is an object of some embodiments of the invention to provide animproved tissue approximation device that uses oppositely orientedthread elements to provide for release of a control wire and extractionof the device as a whole.

It is an object of some embodiments of the invention to provide a methodfor using the device of the first or second objects in the performanceof a minimally invasive tissue approximation procedure.

Other objects and advantages of various embodiments of the inventionwill be apparent to those of skill in the art upon review of theteachings herein. The various embodiments of the invention, set forthexplicitly herein or otherwise ascertained from the teachings herein,may address one or more of the above objects alone or in combination, oralternatively may address some other object ascertained from theteachings herein. It is not necessarily intended that all objects beaddressed by any single aspect of the invention even though that may bethe case with regard to some aspects.

A first aspect of the invention provides a medical instrument forapproximating tissue within a patient's body during a minimally invasivesurgical procedure, including: (a) a first set of expandable elements;(b) a second set of expandable elements; (c) a rail along which thefirst and second sets of expandable elements are located; and (d) alocking mechanism for allowing the first and second sets of expandableelements to be moved to a more proximate positions while inhibitingmovement of the first and second sets of expandable elements to a moredistant relative position along the length of the rail, after beingmoved to a more proximate position; (e) a threaded engagement featurefor engaging a control wire; (f) a seat region for engaging a push tubewherein the wire and the push tube engage relatively movable elementsand that upon relative motion can be made to bring the first and secondset of expandable elements to their more proximate positions; (g) acontrollable stop element that inhibits the distal expansion wings fromextending beyond a desired retention position when located in a firstposition and allows distal axial collapse of the distal wings whenlocated in another position so that the instrument may be extracted inits entirety from the proximal side of the tissue.

Numerous variations of the first aspect of the invention exist andinclude, for example, (1) the device wherein the control wire isrotatable relative to the engagement feature such that upon rotation inone direction the control wire is disengaged while rotation in theopposite direction causes the turning of an oppositely thread screwwhich causes the movement of the stop to the second position, (2) themedical instrument wherein at least one of the first set of expandableelements or the second set of expandable elements include toggle wingsthat pivot open along at least one axis that is perpendicular to alongitudinal axis of the instrument, and (3) the medical instrumentwherein at least one of the first set of expandable elements or thesecond set of expandable elements include wings that expand by pivotingabout at least one axis that is parallel to a longitudinal axis of theinstrument and are actuated via a rotational motion of the instrumentalong its longitudinal axis.

Further variations of the second listed variation of the first aspect ofthe invention include, for example, (a) the medical instrument whereinthe toggle wings expand via a force induced by at least one springlocated within the instrument, and (b) the medical instrument whereinthe other of the first set of expandable elements or the second set ofexpandable elements include toggle wings that pivot open along at leastone axis that is perpendicular to a longitudinal axis of the instrument.

Yet further variations of the 2(b) listed variation of the first aspectof the invention include, for example, (i) the medical instrumentwherein the toggle wings of the other of the first set of expandableelements or the second set of expandable elements expand via a forceinduced by at least one spring located within the instrument.

A second aspect of the invention provides a surgical procedure forapproximating tissue within a patient's body, including: (a) locating anapproximation instrument within the body of a patient at the end of acatheter; the instrument including: (i) a first set of expandableelements; (ii) a second set of expandable elements; (iii) a rail alongwhich the first and second sets of expandable elements are located; and(iv) a locking mechanism for allowing the first and second sets ofexpandable elements to be moved to a more proximate positions whileinhibiting movement of the first and second sets of expandable elementsto a more distant relative position along the length of the rail, afterbeing moved to a more proximate position; (v) a threaded engagementfeature for engaging a control wire; (vi) a seat region for engaging apush tube wherein the wire and the push tube engage relatively movableelements and that upon relative motion can be made to bring the firstand second set of expandable elements to their more proximate positions;(vii) a controllable stop element that inhibits the distal expansionwings from extending beyond a desired retention position when located ina first position and allows distal axial collapse of the distal wingswhen located in another position so that the instrument may be extractedin its entirety from the proximal side of the tissue; (b) inserting adistal end of the instrument through a proximal tissue region and thenthrough a separated distal tissue region; (c) expanding the first set ofexpandable elements (d) locating the first set of expanded elementsagainst a wall of the distal tissue region; (d) expanding the second setof expandable elements (e) locating the second set of expanded elementsagainst a wall of the proximal tissue region; (e) relatively moving thefirst set of expanded elements and the second set of expanded elementstoward one another to bring the proximal and distal tissue regions intoa more proximate position; and (f) releasing at least a portion of theinstrument from the catheter by rotating a portion of the instrument ina first direction via motion of the control wire so that the portion ofinstrument that contains the first and second sets of expanded elementsremains in the body of the patient and retains the distal and proximaltissue regions in the more proximate position.

Numerous variations of the first aspect of the invention exist andinclude, for example, (1) the method wherein the instrument isdisengaged from the distal and proximal tissue regions by rotating the aportion of the instrument in an opposite direction to that of the firstdirection to allow collapse of the distal wings in a distal direction asthe instrument is extracted in a proximal direction.

The disclosure of the present invention provides for the fabrication ofdevices from a plurality of adhered layers wherein each successive layerincludes at least two materials, one of which is a structural materialand the other of which is a sacrificial material, and wherein eachsuccessive layer defines a successive cross-section of thethree-dimensional structure, and wherein the forming of each of theplurality of successive layers includes: (i) depositing a first of theat least two materials, (ii) depositing a second of the at least twomaterials, (ii) planarizing the first and second materials; and afterthe forming of the plurality of successive layers, separating at least aportion of the sacrificial material from the structural material toreveal the three-dimensional structure.

Other aspects of the invention will be understood by those of skill inthe art upon review of the teachings herein. Other aspects of theinvention may involve combinations of the above noted aspects of theinvention. These other aspects of the invention may provide variouscombinations of the aspects presented above as well as provide otherconfigurations, structures, functional relationships, and processes thathave not been specifically set forth above.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C schematically depict side views of various stages of a CCmask plating process, while FIGS. 1D-G schematically depict a side viewsof various stages of a CC mask plating process using a different type ofCC mask.

FIGS. 2A-2F schematically depict side views of various stages of anelectrochemical fabrication process as applied to the formation of aparticular structure where a sacrificial material is selectivelydeposited while a structural material is blanket deposited.

FIGS. 3A-3C schematically depict side views of various examplesubassemblies that may be used in manually implementing theelectrochemical fabrication method depicted in FIGS. 2A-2F.

FIGS. 4A-4F schematically depict the formation of a first layer of astructure using adhered mask plating where the blanket deposition of asecond material overlays both the openings between deposition locationsof a first material and the first material itself

FIG. 4G depicts the completion of formation of the first layer resultingfrom planarizing the deposited materials to a desired level.

FIGS. 4H and 4I respectively depict the state of the process afterformation of the multiple layers of the structure and after release ofthe structure from the sacrificial material.

FIG. 5 depicts the device 100 of the first embodiment along with a pushtube 142 and a control wire 152 that has right hand threads 154-1 on itsdistal end.

FIGS. 6A-6D depict the states of a process for using the device of FIG.5 in approximating two tissue elements which can be followed by removalof the wire and removal of the push tube.

FIGS. 7A-7B illustrate a process for releasing the device of FIG. 5 fromtissue.

FIGS. 8A-8H provide various perspective views of the tissueapproximation device of the second embodiment of the invention whereinthe device is shown in various complete, close-up, and sectioned viewsas well as sectioned views.

FIG. 9 provides a perspective section view of the tissue approximationdevice 200 located within a needle 201 and engaged with its push tube242 and control wire 249.

FIG. 10 provides a perspective view of an independently formed ring 300for engaging a push tube and push tube interface arms.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Electrochemical Fabrication in General

FIGS. 1A-1G, 2A-2F, and 3A-3C illustrate various features of one form ofelectrochemical fabrication. Other electrochemical fabricationtechniques are set forth in the '630 patent referenced above, in thevarious previously incorporated publications, in various other patentsand patent applications incorporated herein by reference. Still othersmay be derived from combinations of various approaches described inthese publications, patents, and applications, or are otherwise known orascertainable by those of skill in the art from the teachings set forthherein. All of these techniques may be combined with those of thevarious embodiments of various aspects of the invention to yieldenhanced embodiments. Still other embodiments may be derived fromcombinations of the various embodiments explicitly set forth herein.

FIGS. 4A-4I illustrate various stages in the formation of a single layerof a multi-layer fabrication process where a second metal is depositedon a first metal as well as in openings in the first metal so that thefirst and second metal form part of the layer. In FIG. 4A a side view ofa substrate 82 is shown, onto which patternable photoresist 84 is castas shown in FIG. 4B. In FIG. 4C, a pattern of resist is shown thatresults from the curing, exposing, and developing of the resist. Thepatterning of the photoresist 84 results in openings or apertures92(a)-92(c) extending from a surface 86 of the photoresist through thethickness of the photoresist to surface 88 of the substrate 82. In FIG.4D a metal 94 (e.g. nickel) is shown as having been electroplated intothe openings 92(a)-92(c). In FIG. 4E the photoresist has been removed(i.e. chemically stripped) from the substrate to expose regions of thesubstrate 82 which are not covered with the first metal 94. In FIG. 4F asecond metal 96 (e.g. silver) is shown as having been blanketelectroplated over the entire exposed portions of the substrate 82(which is conductive) and over the first metal 94 (which is alsoconductive). FIG. 4G depicts the completed first layer of the structurewhich has resulted from the planarization of the first and second metalsdown to a height that exposes the first metal and sets a thickness forthe first layer. In FIG. 4H the result of repeating the process stepsshown in FIGS. 4B-4 G several times to form a multi-layer structure areshown where each layer consists of two materials. For most applications,one of these materials is removed as shown in FIG. 4I to yield a desired3-D structure 98 (e.g. component or device).

Various embodiments of various aspects of the invention are directed toformation of three-dimensional structures from materials some of whichmay be electrodeposited or electroless deposited. Some of thesestructures may be formed form a single build level formed from one ormore deposited materials while others are formed from a plurality ofbuild layers each including at least two materials (e.g. two or morelayers, more preferably five or more layers, and most preferably ten ormore layers). In some embodiments, layer thicknesses may be as small asone micron or as large as fifty microns. In other embodiments, thinnerlayers may be used while in other embodiments, thicker layers may beused. In some embodiments structures having features positioned withmicron level precision and minimum features size on the order of tens ofmicrons are to be formed. In other embodiments structures with lessprecise feature placement and/or larger minimum features may be formed.In still other embodiments, higher precision and smaller minimum featuresizes may be desirable. In the present application meso-scale andmillimeter scale have the same meaning and refer to devices that mayhave one or more dimensions extending into the 0.5-20 millimeter range,or somewhat larger and with features positioned with precision in the10-100 micron range and with minimum features sizes on the order of 100microns.

The various embodiments, alternatives, and techniques disclosed hereinmay form multi-layer structures using a single patterning technique onall layers or using different patterning techniques on different layers.For example, various embodiments of the invention may perform selectivepatterning operations using conformable contact masks and maskingoperations (i.e. operations that use masks which are contacted to butnot adhered to a substrate), proximity masks and masking operations(i.e. operations that use masks that at least partially selectivelyshield a substrate by their proximity to the substrate even if contactis not made), non-conformable masks and masking operations (i.e. masksand operations based on masks whose contact surfaces are notsignificantly conformable), and/or adhered masks and masking operations(masks and operations that use masks that are adhered to a substrateonto which selective deposition or etching is to occur as opposed toonly being contacted to it). Conformable contact masks, proximity masks,and non-conformable contact masks share the property that they arepreformed and brought to, or in proximity to, a surface which is to betreated (i.e. the exposed portions of the surface are to be treated).These masks can generally be removed without damaging the mask or thesurface that received treatment to which they were contacted, or locatedin proximity to. Adhered masks are generally formed on the surface to betreated (i.e. the portion of that surface that is to be masked) andbonded to that surface such that they cannot be separated from thatsurface without being completely destroyed damaged beyond any point ofreuse. Adhered masks may be formed in a number of ways including (1) byapplication of a photoresist, selective exposure of the photoresist, andthen development of the photoresist, (2) selective transfer ofpre-patterned masking material, and/or (3) direct formation of masksfrom computer controlled depositions of material.

Patterning operations may be used in selectively depositing materialand/or may be used in the selective etching of material. Selectivelyetched regions may be selectively filled in or filled in via blanketdeposition, or the like, with a different desired material. In someembodiments, the layer-by-layer build up may involve the simultaneousformation of portions of multiple layers. In some embodiments,depositions made in association with some layer levels may result indepositions to regions associated with other layer levels (i.e. regionsthat lie within the top and bottom boundary levels that define adifferent layer's geometric configuration). Such use of selectiveetching and interlaced material deposition in association with multiplelayers is described in U.S. patent application Ser. No. 10/434,519, bySmalley, now U.S. Pat. No. 7,252,861, and entitled “Methods of andApparatus for Electrochemically Fabricating Structures Via InterlacedLayers or Via Selective Etching and Filling of Voids layer elements”which is hereby incorporated herein by reference as if set forth infull.

Temporary substrates on which structures may be formed may be of thesacrificial-type (i.e. destroyed or damaged during separation ofdeposited materials to the extent they can not be reused),non-sacrificial-type (i.e. not destroyed or excessively damaged, i.e.not damaged to the extent they may not be reused, e.g. with asacrificial or release layer located between the substrate and theinitial layers of a structure that is formed). Non-sacrificialsubstrates may be considered reusable, with little or no rework (e.g.replanarizing one or more selected surfaces or applying a release layer,and the like) though they may or may not be reused for a variety ofreasons.

DEFINITIONS

This section of the specification is intended to set forth definitionsfor a number of specific terms that may be useful in describing thesubject matter of the various embodiments of the invention. It isbelieved that the meanings of most if not all of these terms is clearfrom their general use in the specification but they are set forthhereinafter to remove any ambiguity that may exist. It is intended thatthese definitions be used in understanding the scope and limits of anyclaims that use these specific terms. As far as interpretation of theclaims of this patent disclosure are concerned, it is intended thatthese definitions take presence over any contradictory definitions orallusions found in any materials which are incorporated herein byreference.

“Build” as used herein refers, as a verb, to the process of building adesired structure or plurality of structures from a plurality of appliedor deposited materials which are stacked and adhered upon application ordeposition or, as a noun, to the physical structure or structures formedfrom such a process. Depending on the context in which the term is used,such physical structures may include a desired structure embedded withina sacrificial material or may include only desired physical structureswhich may be separated from one another or may require dicing and/orslicing to cause separation.

“Build axis” or “build orientation” is the axis or orientation that issubstantially perpendicular to substantially planar levels of depositedor applied materials that are used in building up a structure. Theplanar levels of deposited or applied materials may be or may not becompletely planar but are substantially so in that the overall extent oftheir cross-sectional dimensions are significantly greater than theheight of any individual deposit or application of material (e.g. 100,500, 1000, 5000, or more times greater). The planar nature of thedeposited or applied materials may come about from use of a process thatleads to planar deposits or it may result from a planarization process(e.g. a process that includes mechanical abrasion, e.g. lapping, flycutting, grinding, or the like) that is used to remove material regionsof excess height. Unless explicitly noted otherwise, “vertical” as usedherein refers to the build axis or nominal build axis (if the layers arenot stacking with perfect registration) while “horizontal” refers to adirection within the plane of the layers (i.e. the plane that issubstantially perpendicular to the build axis).

“Build layer” or “layer of structure” as used herein does not refer to adeposit of a specific material but instead refers to a region of a buildlocated between a lower boundary level and an upper boundary level whichgenerally defines a single cross-section of a structure being formed orstructures which are being formed in parallel. Depending on the detailsof the actual process used to form the structure, build layers aregenerally formed on and adhered to previously formed build layers. Insome processes the boundaries between build layers are defined byplanarization operations which result in successive build layers beingformed on substantially planar upper surfaces of previously formed buildlayers. In some embodiments, the substantially planar upper surface ofthe preceding build layer may be textured to improve adhesion betweenthe layers. In other build processes, openings may exist in or be formedin the upper surface of a previous but only partially formed buildlayers such that the openings in the previous build layers are filledwith materials deposited in association with current build layers whichwill cause interlacing of build layers and material deposits. Suchinterlacing is described in U.S. patent application Ser. No. 10/434,519now U.S. Pat. No. 7,252,861. This referenced application is incorporatedherein by reference as if set forth in full. In most embodiments, abuild layer includes at least one primary structural material and atleast one primary sacrificial material. However, in some embodiments,two or more primary structural materials may used without a primarysacrificial material (e.g. when one primary structural material is adielectric and the other is a conductive material). In some embodiments,build layers are distinguishable from each other by the source of thedata that is used to yield patterns of the deposits, applications,and/or etchings of material that form the respective build layers. Forexample, data descriptive of a structure to be formed which is derivedfrom data extracted from different vertical levels of a datarepresentation of the structure define different build layers of thestructure. The vertical separation of successive pairs of suchdescriptive data may define the thickness of build layers associatedwith the data. As used herein, at times, “build layer” may be looselyreferred simply as “layer”. In many embodiments, deposition thickness ofprimary structural or sacrificial materials (i.e. the thickness of anyparticular material after it is deposited) is generally greater than thelayer thickness and a net deposit thickness is set via one or moreplanarization processes which may include, for example, mechanicalabrasion (e.g. lapping, fly cutting, polishing, and the like) and/orchemical etching (e.g. using selective or non-selective etchants). Thelower boundary and upper boundary for a build layer may be set anddefined in different ways. From a design point of view they may be setbased on a desired vertical resolution of the structure (which may varywith height). From a data manipulation point of view, the vertical layerboundaries may be defined as the vertical levels at which datadescriptive of the structure is processed or the layer thickness may bedefined as the height separating successive levels of cross-sectionaldata that dictate how the structure will be formed. From a fabricationpoint of view, depending on the exact fabrication process used, theupper and lower layer boundaries may be defined in a variety ofdifferent ways. For example by planarization levels or effectiveplanarization levels (e.g. lapping levels, fly cutting levels, chemicalmechanical polishing levels, mechanical polishing levels, verticalpositions of structural and/or sacrificial materials after relativelyuniform etch back following a mechanical or chemical mechanicalplanarization process). For example, by levels at which process steps oroperations are repeated. At levels at which, at least theoretically,lateral extends of structural material can be changed to define newcross-sectional features of a structure.

“Layer thickness” is the height along the build axis between a lowerboundary of a build layer and an upper boundary of that build layer.

“Planarization” is a process that tends to remove materials, above adesired plane, in a substantially non-selective manner such that alldeposited materials are brought to a substantially common height ordesired level (e.g. within 20%, 10%, 5%, or even 1% of a desired layerboundary level). For example, lapping removes material in asubstantially non-selective manner though some amount of recession onematerial or another may occur (e.g. copper may recess relative tonickel). Planarization may occur primarily via mechanical means, e.g.lapping, grinding, fly cutting, milling, sanding, abrasive polishing,frictionally induced melting, other machining operations, or the like(i.e. mechanical planarization). Mechanical planarization maybe followedor proceeded by thermally induced planarization (.e.g. melting) orchemically induced planarization (e.g. etching). Planarization may occurprimarily via a chemical and/or electrical means (e.g. chemical etching,electrochemical etching, or the like). Planarization may occur via asimultaneous combination of mechanical and chemical etching (e.g.chemical mechanical polishing (CMP)).

“Structural material” as used herein refers to a material that remainspart of the structure when put into use.

“Supplemental structural material” as used herein refers to a materialthat forms part of the structure when the structure is put to use but isnot added as part of the build layers but instead is added to aplurality of layers simultaneously (e.g. via one or more coatingoperations that applies the material, selectively or in a blanketfashion, to a one or more surfaces of a desired build structure that hasbeen released from a sacrificial material.

“Primary structural material” as used herein is a structural materialthat forms part of a given build layer and which is typically depositedor applied during the formation of that build layer and which makes upmore than 20% of the structural material volume of the given buildlayer. In some embodiments, the primary structural material may be thesame on each of a plurality of build layers or it may be different ondifferent build layers. In some embodiments, a given primary structuralmaterial may be formed from two or more materials by the alloying ordiffusion of two or more materials to form a single material.

“Secondary structural material” as used herein is a structural materialthat forms part of a given build layer and is typically deposited orapplied during the formation of the given build layer but is not aprimary structural material as it individually accounts for only a smallvolume of the structural material associated with the given layer. Asecondary structural material will account for less than 20% of thevolume of the structural material associated with the given layer. Insome preferred embodiments, each secondary structural material mayaccount for less than 10%, 5%, or even 2% of the volume of thestructural material associated with the given layer. Examples ofsecondary structural materials may include seed layer materials,adhesion layer materials, barrier layer materials (e.g. diffusionbarrier material), and the like. These secondary structural materialsare typically applied to form coatings having thicknesses less than 2microns, 1 micron, 0.5 microns, or even 0.2 microns). The coatings maybe applied in a conformal or directional manner (e.g. via CVD, PVD,electroless deposition, or the like). Such coatings may be applied in ablanket manner or in a selective manner. Such coatings may be applied ina planar manner (e.g. over previously planarized layers of material) astaught in U.S. patent application Ser. No. 10/607,931, now U.S. Pat. No.7,239,219. In other embodiments, such coatings may be applied in anon-planar manner, for example, in openings in and over a patternedmasking material that has been applied to previously planarized layersof material as taught in U.S. patent application Ser. No. 10/841,383,now U.S. Pat. No. 7,195,989. These referenced applications areincorporated herein by reference as if set forth in full herein.

“Functional structural material” as used herein is a structural materialthat would have been removed as a sacrificial material but for itsactual or effective encapsulation by other structural materials.Effective encapsulation refers, for example, to the inability of anetchant to attack the functional structural material due toinaccessibility that results from a very small area of exposure and/ordue to an elongated or tortuous exposure path. For example, large(10,000 μm²) but thin (e.g. less than 0.5 microns) regions ofsacrificial copper sandwiched between deposits of nickel may defineregions of functional structural material depending on ability of arelease etchant to remove the sandwiched copper.

“Sacrificial material” is material that forms part of a build layer butis not a structural material. Sacrificial material on a given buildlayer is separated from structural material on that build layer afterformation of that build layer is completed and more generally is removedfrom a plurality of layers after completion of the formation of theplurality of layers during a “release” process that removes the bulk ofthe sacrificial material or materials. In general sacrificial materialis located on a build layer during the formation of one, two, or moresubsequent build layers and is thereafter removed in a manner that doesnot lead to a planarized surface. Materials that are applied primarilyfor masking purposes, i.e. to allow subsequent selective deposition oretching of a material, e.g. photoresist that is used in forming a buildlayer but does not form part of the build layer) or that exist as partof a build for less than one or two complete build layer formationcycles are not considered sacrificial materials as the term is usedherein but instead shall be referred as masking materials or astemporary materials. These separation processes are sometimes referredto as a release process and may or may not involve the separation ofstructural material from a build substrate. In many embodiments,sacrificial material within a given build layer is not removed until allbuild layers making up the three-dimensional structure have been formed.Of course sacrificial material may be, and typically is, removed fromabove the upper level of a current build layer during planarizationoperations during the formation of the current build layer. Sacrificialmaterial is typically removed via a chemical etching operation but insome embodiments may be removed via a melting operation orelectrochemical etching operation. In typical structures, the removal ofthe sacrificial material (i.e. release of the structural material fromthe sacrificial material) does not result in planarized surfaces butinstead results in surfaces that are dictated by the boundaries ofstructural materials located on each build layer. Sacrificial materialsare typically distinct from structural materials by having differentproperties therefrom (e.g. chemical etchability, hardness, meltingpoint, etc.) but in some cases, as noted previously, what would havebeen a sacrificial material may become a structural material by itsactual or effective encapsulation by other structural materials.Similarly, structural materials may be used to form sacrificialstructures that are separated from a desired structure during a releaseprocess via the sacrificial structures being only attached tosacrificial material or potentially by dissolution of the sacrificialstructures themselves using a process that is insufficient to reachstructural material that is intended to form part of a desiredstructure. It should be understood that in some embodiments, smallamounts of structural material may be removed, after or during releaseof sacrificial material. Such small amounts of structural material mayhave been inadvertently formed due to imperfections in the fabricationprocess or may result from the proper application of the process but mayresult in features that are less than optimal (e.g. layers with stairssteps in regions where smooth sloped surfaces are desired. In such casesthe volume of structural material removed is typically minusculecompared to the amount that is retained and thus such removal is ignoredwhen labeling materials as sacrificial or structural. Sacrificialmaterials are typically removed by a dissolution process, or the like,that destroys the geometric configuration of the sacrificial material asit existed on the build layers. In many embodiments, the sacrificialmaterial is a conductive material such as a metal. As will be discussedhereafter, masking materials though typically sacrificial in nature arenot termed sacrificial materials herein unless they meet the requireddefinition of sacrificial material.

“Supplemental sacrificial material” as used herein refers to a materialthat does not form part of the structure when the structure is put touse and is not added as part of the build layers but instead is added toa plurality of layers simultaneously (e.g. via one or more coatingoperations that applies the material, selectively or in a blanketfashion, to a one or more surfaces of a desired build structure that hasbeen released from an initial sacrificial material. This supplementalsacrificial material will remain in place for a period of time and/orduring the performance of certain post layer formation operations, e.g.to protect the structure that was released from a primary sacrificialmaterial, but will be removed prior to putting the structure to use.

“Primary sacrificial material” as used herein is a sacrificial materialthat is located on a given build layer and which is typically depositedor applied during the formation of that build layer and which makes upmore than 20% of the sacrificial material volume of the given buildlayer. In some embodiments, the primary sacrificial material may be thesame on each of a plurality of build layers or may be different ondifferent build layers. In some embodiments, a given primary sacrificialmaterial may be formed from two or more materials by the alloying ordiffusion of two or more materials to form a single material.

“Secondary sacrificial material” as used herein is a sacrificialmaterial that is located on a given build layer and is typicallydeposited or applied during the formation of the build layer but is nota primary sacrificial materials as it individually accounts for only asmall volume of the sacrificial material associated with the givenlayer. A secondary sacrificial material will account for less than 20%of the volume of the sacrificial material associated with the givenlayer. In some preferred embodiments, each secondary sacrificialmaterial may account for less than 10%, 5%, or even 2% of the volume ofthe sacrificial material associated with the given layer. Examples ofsecondary structural materials may include seed layer materials,adhesion layer materials, barrier layer materials (e.g. diffusionbarrier material), and the like. These secondary sacrificial materialsare typically applied to form coatings having thicknesses less than 2microns, 1 micron, 0.5 microns, or even 0.2 microns). The coatings maybe applied in a conformal or directional manner (e.g. via CVD, PVD,electroless deposition, or the like). Such coatings may be applied in ablanket manner or in a selective manner. Such coatings may be applied ina planar manner (e.g. over previously planarized layers of material) astaught in U.S. patent application Ser. No. 10/607,931, now U.S. Pat. No.7,239,219. In other embodiments, such coatings may be applied in anon-planar manner, for example, in openings in and over a patternedmasking material that has been applied to previously planarized layersof material as taught in U.S. patent application Ser. No. 10/841,383,now U.S. Pat. No. 7,195,989. These referenced applications areincorporated herein by reference as if set forth in full herein.

“Adhesion layer”, “seed layer”, “barrier layer”, and the like refer tocoatings of material that are thin in comparison to the layer thicknessand thus generally form secondary structural material portions orsacrificial material portions of some layers. Such coatings may beapplied uniformly over a previously formed build layer, they may beapplied over a portion of a previously formed build layer and overpatterned structural or sacrificial material existing on a current (i.e.partially formed) build layer so that a non-planar seed layer results,or they may be selectively applied to only certain locations on apreviously formed build layer. In the event such coatings arenon-selectively applied, selected portions may be removed (1) prior todepositing either a sacrificial material or structural material as partof a current layer or (2) prior to beginning formation of the next layeror they may remain in place through the layer build up process and thenetched away after formation of a plurality of build layers.

“Masking material” is a material that may be used as a tool in theprocess of forming a build layer but does not form part of that buildlayer. Masking material is typically a photopolymer or photoresistmaterial or other material that may be readily patterned. Maskingmaterial is typically a dielectric. Masking material, though typicallysacrificial in nature, is not a sacrificial material as the term is usedherein. Masking material is typically applied to a surface during theformation of a build layer for the purpose of allowing selectivedeposition, etching, or other treatment and is removed either during theprocess of forming that build layer or immediately after the formationof that build layer.

“Multilayer structures” are structures formed from multiple build layersof deposited or applied materials.

“Multilayer three-dimensional (or 3D or 3-D) structures” are MultilayerStructures that meet at least one of two criteria: (1) the structuralmaterial portion of at least two layers of which one has structuralmaterial portions that do not overlap structural material portions ofthe other.

“Complex multilayer three-dimensional (or 3D or 3-D) structures” aremultilayer three-dimensional structures formed from at least threelayers where a line may be defined that hypothetically extendsvertically through at least some portion of the build layers of thestructure will extend from structural material through sacrificialmaterial and back through structural material or will extend fromsacrificial material through structural material and back throughsacrificial material (these might be termed vertically complexmultilayer three-dimensional structures). Alternatively, complexmultilayer three-dimensional structures may be defined as multilayerthree-dimensional structures formed from at least two layers where aline may be defined that hypothetically extends horizontally through atleast some portion of a build layer of the structure that will extendfrom structural material through sacrificial material and back throughstructural material or will extend from sacrificial material throughstructural material and back through sacrificial material (these mightbe termed horizontally complex multilayer three-dimensional structures).Worded another way, in complex multilayer three-dimensional structures,a vertically or horizontally extending hypothetical line will extendfrom one or structural material or void (when the sacrificial materialis removed) to the other of void or structural material and then back tostructural material or void as the line is traversed along at least aportion of the line.

“Moderately complex multilayer three-dimensional (or 3D or 3-D)structures are complex multilayer 3D structures for which thealternating of void and structure or structure and void not only existsalong one of a vertically or horizontally extending line but along linesextending both vertically and horizontally.

“Highly complex multilayer (or 3D or 3-D) structures are complexmultilayer 3D structures for which the structure-to-void-to-structure orvoid-to-structure-to-void alternating occurs once along the line butoccurs a plurality of times along a definable horizontally or verticallyextending line.

“Up-facing feature” is an element dictated by the cross-sectional datafor a given build layer “n” and a next build layer “n+1” that is to beformed from a given material that exists on the build layer “n” but doesnot exist on the immediately succeeding build layer “n+1”. Forconvenience the term “up-facing feature” will apply to such featuresregardless of the build orientation.

“Down-facing feature” is an element dictated by the cross-sectional datafor a given build layer “n” and a preceding build layer “n−1” that is tobe formed from a given material that exists on build layer “n” but doesnot exist on the immediately preceding build layer “n−1”. As withup-facing features, the term “down-facing feature” shall apply to suchfeatures regardless of the actual build orientation.

“Continuing region” is the portion of a given build layer “n” that isdictated by the cross-sectional data for the given build layer “n”, anext build layer “n+1” and a preceding build layer “n−1” that is neitherup-facing nor down-facing for the build layer “n”.

“Minimum feature size” or “MFS” refers to a necessary or desirablespacing between structural material elements on a given layer that areto remain distinct in the final device configuration. If the minimumfeature size is not maintained for structural material elements on agiven layer, the fabrication process may result in structural materialinadvertently bridging what were intended to be two distinct elements(e.g. due to masking material failure or failure to appropriately fillvoids with sacrificial material during formation of the given layer suchthat during formation of a subsequent layer structural materialinadvertently fills the void). More care during fabrication can lead toa reduction in minimum feature size. Alternatively, a willingness toaccept greater losses in productivity (i.e. lower yields) can result ina decrease in the minimum feature size. However, during fabrication fora given set of process parameters, inspection diligence, and yield(successful level of production) a minimum design feature size is set inone way or another. The above described minimum feature size may moreappropriately be termed minimum feature size of gaps or voids (e.g. theMFS for sacrificial material regions when sacrificial material isdeposited first). Conversely a minimum feature size for structurematerial regions (minimum width or length of structural materialelements) may be specified. Depending on the fabrication method andorder of deposition of structural material and sacrificial material, thetwo types of minimum feature sizes may be the same or different. Inpractice, for example, using electrochemical fabrication methods asdescribed herein, the minimum features size on a given layer may beroughly set to a value that approximates the layer thickness used toform the layer and it may be considered the same for both structural andsacrificial material widths. In some more rigorously implementedprocesses (e.g. with higher examination regiments and tolerance forrework), it may be set to an amount that is 80%, 50%, or even 30% of thelayer thickness. Other values or methods of setting minimum featuresizes may be used. Worded another way, depending on the geometry of astructure, or plurality of structures, being formed, the structure, orstructures, may include elements (e.g. solid regions) which havedimensions smaller than a first minimum feature size and/or havespacings, voids, openings, or gaps (e.g. hollow or empty regions)located between elements, where the spacings are smaller than a secondminimum feature size where the first and second minimum feature sizesmay be the same or different and where the minimum feature sizesrepresent lower limits at which formation of elements and/or spacing canbe reliably formed. Reliable formation refers to the ability toaccurately form or produce a given geometry of an element, or of thespacing between elements, using a given formation process, with aminimum acceptable yield. The minimum acceptable yield may depend on anumber of factors including: (1) number of features present per layer,(2) numbers of layers, (3) the criticality of the successful formationof each feature, (4) the number and severity of other factors effectingoverall yield, and (5) the desired or required overall yield for thestructures or devices themselves. In some circumstances, the minimumsize may be determined by a yield requirement per feature which is aslow as 70%, 60%, or even 50%. While in other circumstances the yieldrequirement per feature may be as high as 90%, 95%, 99%, or even higher.In some circumstances (e.g. in producing a filter element) the failureto produce a certain number of desired features (e.g. 20-40% failure maybe acceptable while in an electrostatic actuator the failure to producea single small space between two moveable electrodes may result infailure of the entire device. The MFS, for example, may be defined asthe minimum width of a narrow and processing element (e.g. photoresistelement or sacrificial material element) or structural element (e.g.structural material element) that may be reliably formed (e.g. 90-99.9times out of 100) which is either independent of any wider structures orhas a substantial independent length (e.g. 200-1000 microns) beforeconnecting to a wider region.

“Sublayer” as used herein refers to a portion of a build layer thattypically includes the full lateral extents of that build layer but onlya portion of its height. A sublayer is usually a vertical portion ofbuild layer that undergoes independent processing compared to anothersublayer of that build layer.

Tissue Approximation Devices, Methods for Use, and Methods for Making

Previous designs of tissue approximation devices are set forth in U.S.patent application Ser. Nos. 11/591,911, 11/598,968, 11/625,807, and12/346,034. Each of these referenced applications is hereby incorporatedherein by reference as if set forth in full.

Herein after, two primary device embodiments and one method of useembodiment are described. FIG. 5 depicts the device 100 of the firstembodiment along with a push tube 142 and a control wire 152 that hasright hand threads 154-1 on its distal end. The device 100 of thisembodiment includes a number of elements: (1) distal expandable wings106-1 and 106-2; (2) proximal expanding wings 146-1 and 146-2, (3) adistal body portion 102 in the form of a rail including teeth 112 forengaging a ratcheting catch 162, a proximal end including a left handedthreaded female receptacle 156-2 for engaging left handed male threadedelement 156-1 located between a translatable stop bar 158 and right handthreaded female control wire receptacle 154-2, a distal end to whichdistal wings 106-1 and 106-2 are pivotably mounted via pivots 104-1 and104-2, (4) a more proximal body portion 140 in the form of proximalsleeve to which wings 146-1 and 146-2 mount via pivots 144-1 and 144-2and from which deflection arms distally extend to catch heads 162wherein the proximal body portion can ratchetably slide longitudinallyrelative to the more distal body portion 102 to bring the distal andproximal wings into closer proximity. The device also includes a stopbar 158 having an intermediate left hand threaded element or portion156-1 that rotatably engages a left-handed threaded element 156-2 of theproximal body portion with the threaded element giving way moreproximally to a right handed female threaded receptacle 154-2 thatengaged the right handed threaded element 154-1 of the control wire 152.While located in one position (i.e. a more distal position relative tobody portion 102) the stop inhibits the distal wings from opening beyonda perpendicular orientation but while in a second position (i.e. aretracted or more proximal position) the stop allows the distal wings106-1 and 106-2 to rotate past the perpendicular to collapse distally toa more axial orientation beyond the distal wing pivots 104-1 and 104-2.Upon rotating the wire counterclockwise relative to the stop, the wirecan be disengaged from its retained position. On the other hand,rotating the wire clockwise relative to the stop results in completeseating of the wire and eventual rotation of the stop relative to thedistal body which, because of the left handed threading, can result inthe proximal movement of the stop and the distal collapse of the distalwing elements.

FIGS. 6A-6D depict the states of a process for using the device of FIG.5 in approximating two tissue elements which can be followed by removalof the wire and removal of the push tube. FIG. 6A depicts the state ofthe process after insertion of a needle 101 carrying the approximationdevice 100 through both the proximal tissue 191 and the distal tissue192. FIG. 6B depicts the state of the process after withdrawal of theneedle 101 in direction 171 allowing the distal and proximal wings ofdevice 100 to open on opposite sides of the tissue elements. FIG. 6Cdepicts the state of the process after the wire has been pulled indirection 173 relative to the push tube to cause approximation of thetwo tissue elements via the bringing together of the proximal and distalwings into more proximate positions. This more proximate positioning isheld by the ratcheting rail of body portion 102 and catch mechanismassociated with body portion 140. FIG. 6D depicts the state of theprocess after the wire has been rotated in counterclockwise direction175 and moved in direction 177 to release it from the proximal end ofthe more proximal body. The tube may be retained by the device 100 in avariety of non-rotatable releasable ways, such as for example by boththe tube and the proximal end of the proximal body portion containingflats or ridges that inhibit rotational motion by allow axial slidingduring release. Sliding to release may be inhibited in a variety ofways, such as for example, by frictional force, break away tabs,flexures with retention notches that are inhibited from opening so longat the control wire is engaged.

FIGS. 7A-7B illustrate a process for releasing the device of FIG. 5 fromtissue. FIG. 7A depicts the state of the process either before releaseof the wire or after reintroduction of the wire into the proximal end ofthe stop body via a clockwise rotation in direction 181 and aftercontinued rotation in direction 181 to cause relative proximal motion indirection 183 of the stop relative to the body portions 102 and 163 andclearance between the stop and the inner ends of the distal wings. FIG.7B depicts the state of the process after continued clockwise rotationof the wire relative to the approximation device such that the stopelement is moved sufficiently proximally relative to the distal wings toallows for the collapse of the distal wings and the extraction of theapproximation device by pulling in direction 185.

FIGS. 8A-8H provide various perspective views of the tissueapproximation device of the second embodiment of the invention whereinthe device is shown in various complete, close-up, and sectioned viewsas well as sectioned views while FIG. 9 shows the device of FIGS. 8A-8Hin conjunction with other elements with which it is combined to performan approximation procedure.

FIGS. 8A and 8B show two different perspective views of an approximationdevice 200 according to a second device embodiment where distal wings206 and proximal wings 246 can be seen along with central ratchetingrail 202, stop rod 260, and proximal body portion 240. FIGS. 8C-8Hprovide perspective and sectioned close up views of various componentsand features of the device 200. The proximal body portion 240 that holdsthe proximal wings 246 can move longitudinally or axially along theratcheting rail 202 to positions more proximate to the distal wings 206.The rod element 260 at its distal end provides a stop 258 for preventingdistal wings from opening too wide and on its proximal end forms athreaded female attachment area 254-2, for the right handed threadcontrol wire coupler which includes threaded element 254-1 and sleeve251, as well as providing a left-handed male thread element 256-1 thatengages the proximal body, via left handed female thread region 256-2,that holds the proximal wings 246. As can be seen in FIGS. 8A and 8B themoveable rod is held to the ratcheting rail by a plurality of ring-likeelements which ensure that the rod maintains the right positioning withregard to the rail so that the stop function for limiting the motion ofdistal wings can effectively occur.

FIGS. 8C and 8D provide different perspective close-up views of theproximal end of the device 200 where the slidable proximal body element240 holding the proximal wings 246 can be seen along with a pusher tubeinterface 241 and left-handed and right-handed thread engagement areas256 and 254. Springs 245 can be used to at least partially spread wings246 by causing them to pivot about pivot rings 244.

FIG. 8E provides a close-up view of the distal end of the device 200where the wing stop 258 may be seen along with deployment springs 205that force the wings 206 to pivot about pivot rings 204 from a closedconfiguration (e.g. proximal axial alignment) to an at least partiallyopen or radial configuration.

FIG. 8 f provides a close-up view of the stop rod 260 and rod guideelements 261 that maintain the rod and ratcheting mechanisms in axiallytranslatable positions while inhibiting other degrees of freedom.

FIG. 8G provides a sectioned perspective view of the proximal bodyportion and related elements providing views of the right handed femalethreads 254-2 of the rod, the right handed male threads of the wirecoupler 254-1, the left-handed male threads 256-1 of the rod, and lefthanded female threads 256-2 of the ratcheting rail, and catch head 262with release feature 263 located at the distal end of a compliant arm(not labeled), secondary catch head 262-2, and spring 245 for at leastpartially spreading proximal wing 246 via rotation of pins 243withinproximal rings 244.

FIG. 8H provides a close-up sectioned perspective view of the distal endof the device whereby wings 206, wing pivot elements, including pivotring 204, pivot pins 203, and expansion springs 205 can be seen alongwith the wing stop 258 and rod 260.

FIG. 9 provides a perspective section view of the tissue approximationdevice 200 located within a needle 201 and engaged with its push tube242 and control wire 249. As can be seen the wings of the approximationdevice are pressed to axial positions by the inner wall of the needle.

FIG. 10 provides a perspective view of an independently formed ring 300for engaging a push tube and push tube interface arms. The ring includesflats 301 for engaging flat surfaces of the push tube interface arms.This ring may be used as a coupling device for engaging a push tube 242with the push tube interface 241 of FIGS. 8C and 8D. This device may beformed by electrochemical fabrication methods but for efficiency offormation is preferably formed separately from the instrument so that itmay be formed with an optimal orientation, layer count, and the like.This coupling device may be bonded to the push tube and slid from thepush tube interface arms when the procedure is completed. In somealternative embodiments, the pusher tube interface and/or the couplingdevice may be formed with slots and fingers for providing morerotational control than that which may be offered by the flats of theillustrated design. In still other embodiment the coupling mechanism maybe bonded to the pusher tube interface in which case it would bereleasably attached to the tube.

Numerous variation of the above described embodiment are possible andwill be apparent to those of skill in the art upon review of theteachings herein. Some such variations are extractable for the teachingsset forth in the various applications, patents, and papers incorporatedherein by reference.

FURTHER COMMENTS AND CONCLUSIONS

Structural or sacrificial dielectric materials may be incorporated intoembodiments of the present invention in a variety of different ways.Such materials may form a third material or higher deposited on selectedlayers or may form one of the first two materials deposited on somelayers. Additional teachings concerning the formation of structures ondielectric substrates and/or the formation of structures thatincorporate dielectric materials into the formation process andpossibility into the final structures as formed are set forth in anumber of patent applications filed Dec. 31, 2003. The first of thesefilings is U.S. Patent Application No. 60/534,184 which is entitled“Electrochemical Fabrication Methods Incorporating Dielectric Materialsand/or Using Dielectric Substrates”. The second of these filings is U.S.Patent Application No. 60/533,932, which is entitled “ElectrochemicalFabrication Methods Using Dielectric Substrates”. The third of thesefilings is U.S. Patent Application No. 60/534,157, which is entitled“Electrochemical Fabrication Methods Incorporating DielectricMaterials”. The fourth of these filings is U.S. Patent Application No.60/533,891, which is entitled “Methods for Electrochemically FabricatingStructures Incorporating Dielectric Sheets and/or Seed layers That ArePartially Removed Via Planarization”. A fifth such filing is U.S. PatentApplication No. 60/533,895, which is entitled “ElectrochemicalFabrication Method for Producing Multi-layer Three-DimensionalStructures on a Porous Dielectric”. Additional patent filings thatprovide teachings concerning incorporation of dielectrics into the EFABprocess include U.S. patent application Ser. No. 11/139,262, filed May26, 2005 by Lockard, et al., and which is entitled “Methods forElectrochemically Fabricating Structures Using Adhered Masks,Incorporating Dielectric Sheets, and/or Seed Layers that are PartiallyRemoved Via Planarization”; and U.S. patent application Ser. No.11/029,216, filed Jan. 3, 2005 by Cohen, et al., now abandoned, andwhich is entitled “Electrochemical Fabrication Methods IncorporatingDielectric Materials and/or Using Dielectric Substrates”. These patentfilings are each hereby incorporated herein by reference as if set forthin full herein.

Some embodiments may employ diffusion bonding or the like to enhanceadhesion between successive layers of material. Various teachingsconcerning the use of diffusion bonding in electrochemical fabricationprocesses are set forth in U.S. patent application Ser. No. 10/841,384which was filed May 7, 2004 by Cohen et al., now abandoned, which isentitled “Method of Electrochemically Fabricating Multilayer StructuresHaving Improved Interlayer Adhesion” and which is hereby incorporatedherein by reference as if set forth in full. This application is herebyincorporated herein by reference as if set forth in full.

Some embodiments may incorporate elements taught in conjunction withother medical devices as set forth in various U.S. patent applicationsfiled by the owner of the present application and/or may benefit fromcombined use with these other medical devices: Some of these alternativedevices have been described in the following previously filed patentapplications: (1) U.S. patent application Ser. No. 11/478,934, by Cohenet al., and entitled “Electrochemical Fabrication ProcessesIncorporating Non-Platable Materials and/or Metals that are Difficult toPlate On”; (2) U.S. patent application Ser. No. 11/582,049, by Cohen,and entitled “Discrete or Continuous Tissue Capture Device and Methodfor Making”; (3) U.S. patent application Ser. No. 11/625,807, by Cohen,and entitled “Microdevices for Tissue Approximation and Retention,Methods for Using, and Methods for Making”; (4) U.S. patent applicationSer. No. 11/696,722, by Cohen, and entitled “Biopsy Devices, Methods forUsing, and Methods for Making”; (5) U.S. patent application Ser. No.11/734,273, by Cohen, and entitled “Thrombectomy Devices and Methods forMaking”; (6) U.S. Patent Application No. 60/942,200, by Cohen, andentitled “Micro-Umbrella Devices for Use in Medical Applications andMethods for Making Such Devices”; and (7) U.S. patent application Ser.No. 11/444,999, by Cohen, and entitled “Microtools and Methods forFabricating Such Tools”. Each of these applications is incorporatedherein by reference as if set forth in full herein.

Though the embodiments explicitly set forth herein have consideredmulti-material layers to be formed one after another. In someembodiments, it is possible to form structures on a layer-by-layer basisbut to deviate from a strict planar layer on planar layer build upprocess in favor of a process that interlaces material between thelayers. Such alternative build processes are disclosed in U.S.application Ser. No. 10/434,519, filed on May 7, 2003, now U.S. Pat. No.7,252,861, entitled Methods of and Apparatus for ElectrochemicallyFabricating Structures Via Interlaced Layers or Via Selective Etchingand Filling of Voids. The techniques disclosed in this referencedapplication may be combined with the techniques and alternatives setforth explicitly herein to derive additional alternative embodiments. Inparticular, the structural features are still defined on aplanar-layer-by-planar-layer basis but material associated with somelayers are formed along with material for other layers such thatinterlacing of deposited material occurs. Such interlacing may lead toreduced structural distortion during formation or improved interlayeradhesion. This patent application is herein incorporated by reference asif set forth in full.

The patent applications and patents set forth below are herebyincorporated by reference herein as if set forth in full. The teachingsin these incorporated applications can be combined with the teachings ofthe instant application in many ways: For example, enhanced methods ofproducing structures may be derived from some combinations of teachings,enhanced structures may be obtainable, enhanced apparatus may bederived, and the like.

U.S. patent application Ser. No., Filing Date U.S. application Pub No.,Pub Date U.S. Pat. No., Pub Date Inventor, Title 09/493,496 - Jan. 28,2000 Cohen, “Method For Electrochemical Fabrication” U.S. Pat. No.6,790,377 - Sep. 14, 2004 10/677,556 - Oct. 1, 2003 Cohen, “MonolithicStructures Including 2004-0134772 - Jul. 15, 2004 Alignment and/orRetention Fixtures for Accepting Components” 10/830,262 - Apr. 21, 2004Cohen, “Methods of Reducing Interlayer 2004-0251142A - Dec. 16, 2004Discontinuities in Electrochemically Fabricated U.S. Pat. No.7,198,704 - Apr. 3, 2007 Three-Dimensional Structures” 10/271,574 -Oct.15, 2002 Cohen, “Methods of and Apparatus for Making 2003-0127336A -July 10, 2003 High Aspect Ratio Microelectromechanical U.S. Pat. No.7,288,178 - Oct. 30, 2007 Structures” 10/697,597 - Dec. 20, 2002Lockard, “EFAB Methods and Apparatus 2004-0146650A - Jul. 29, 2004Including Spray Metal or Powder Coating Processes” 10/677,498 - Oct. 1,2003 Cohen, “Multi-cell Masks and Methods and 2004-0134788 - Jul. 15,2004 Apparatus for Using Such Masks To Form Three- U.S. Pat. No.7,235,166 - Jun. 26, 2007 Dimensional Structures” 10/724,513 - Nov. 26,2003 Cohen, “Non-Conformable Masks and Methods 2004-0147124 - Jul. 29,2004 and Apparatus for Forming Three-Dimensional U.S. Pat. No.7,368,044 - May 6, 2008 Structures” 10/607,931 - Jun. 27, 2003 Brown,“Miniature RF and Microwave 2004-0140862 - Jul. 22, 2004 Components andMethods for Fabricating Such U.S. Pat. No. 7,239,219 - Jul. 3, 2007Components” 10/841,100 - May 7, 2004 Cohen, “Electrochemical FabricationMethods 2005-0032362 - Feb. 10, 2005 Including Use of Surface Treatmentsto Reduce U.S. Pat. No. 7,109,118 - Sep. 19, 2006 Overplating and/orPlanarization During Formation of Multi-layer Three- DimensionalStructures” 10/387,958 - Mar. 13, 2003 Cohen, “ElectrochemicalFabrication Method and 2003-022168A - Dec. 4, 2003 Application forProducing Three-Dimensional Structures Having Improved Surface Finish ”10/434,494 - May 7, 2003 Zhang, “Methods and Apparatus for Monitoring2004-0000489A - Jan. 1, 2004 Deposition Quality During ConformableContact Mask Plating Operations” 10/434,289 - May 7, 2003 Zhang,“Conformable Contact Masking Methods 20040065555A - Apr. 8, 2004 andApparatus Utilizing In Situ Cathodic Activation of a Substrate”10/434,294 - May 7, 2003 Zhang, “Electrochemical Fabrication Methods2004-0065550A - Apr. 8, 2004 With Enhanced Post Deposition Processing”10/434,295 - May 7, 2003 Cohen, “Method of and Apparatus for Forming2004-0004001A - Jan. 8, 2004 Three-Dimensional Structures Integral WithSemiconductor Based Circuitry” 10/434,315 - May 7, 2003 Bang, “Methodsof and Apparatus for Molding 2003-0234179 A - Dec. 25, 2003 StructuresUsing Sacrificial Metal Patterns” U.S. Pat. No. 7,229,542 - Jun. 12,2007 10/434,103 - May 7, 2004 Cohen, “Electrochemically Fabricated2004-0020782A - Feb. 5, 2004 Hermetically Sealed Microstructures andMethods U.S. Pat. No. 7,160,429 - Jan. 9, 2007 of and Apparatus forProducing Such Structures” 10/841,006 - May 7, 2004 Thompson,“Electrochemically Fabricated 2005-0067292 - May 31, 2005 StructuresHaving Dielectric or Active Bases and Methods of and Apparatus forProducing Such Structures” 10/434,519 - May 7, 2003 Smalley, “Methods ofand Apparatus for 2004-0007470A - Jan. 15, 2004 ElectrochemicallyFabricating Structures Via U.S. Pat. No. 7,252,861 - Aug. 7, 2007Interlaced Layers or Via Selective Etching and Filling of Voids”10/724,515 - Nov. 26, 2003 Cohen, “Method for Electrochemically Forming2004-0182716 - Sep. 23, 2004 Structures Including Non-Parallel Mating ofapplication Ser. No. 7,291,254 - Contact Masks and Substrates” Nov. 6,2007 10/841,347 - May 7, 2004 Cohen, “Multi-step Release Method for2005-0072681 - Apr. 7, 2005 Electrochemically Fabricated Structures”60/533,947 - Dec. 31, 2003 Kumar, “Probe Arrays and Method for Making”60/534,183 - Dec. 31, 2003 Cohen, “Method and Apparatus for MaintainingParallelism of Layers and/or Achieving Desired Thicknesses of LayersDuring the Electrochemical Fabrication of Structures” 11/733,195 - Apr.9, 2007 Kumar, “Methods of Forming Three-Dimensional 2008-0050524 - Feb.28, 2008 Structures Having Reduced Stress and/or Curvature” 11/506,586 -Aug. 8, 2006 Cohen, “Mesoscale and Microscale Device 20007-0039828 -Feb. 22, 2007 Fabrication Methods Using Split Structures and AlignmentElements” 10/949,744 - Sep. 24, 2004 Lockard, “Three-DimensionalStructures Having 2005-0126916 - Jun. 16, 2005 Feature Sizes SmallerThan a Minimum Feature Size and Methods for Fabricating”

Though various portions of this specification have been provided withheaders, it is not intended that the headers be used to limit theapplication of teachings found in one portion of the specification fromapplying to other portions of the specification. For example, it shouldbe understood that alternatives acknowledged in association with oneembodiment, are intended to apply to all embodiments to the extent thatthe features of the different embodiments make such applicationfunctional and do not otherwise contradict or remove all benefits of theadopted embodiment. Various other embodiments of the present inventionexist. Some of these embodiments may be based on a combination of theteachings herein with various teachings incorporated herein byreference.

In view of the teachings herein, many further embodiments, alternativesin design and uses of the embodiments of the instant invention will beapparent to those of skill in the art. As such, it is not intended thatthe invention be limited to the particular illustrative embodiments,alternatives, and uses described above but instead that it be solelylimited by the claims presented hereafter.

We claim:
 1. A surgical procedure for approximating tissue within apatient's body, comprising: (a) locating an approximation instrumentwithin a body of a patient at an end of a catheter wherein theapproximation instrument is functionally engaged with a control wire anda push tube; the instrument comprising: (i) a first set of expandableelements; (ii) a second set of expandable elements; (iii) a rail alongwhich the first and second sets of expandable elements are located; and(iv) a locking mechanism for allowing the first and second sets ofexpandable elements to be relatively moved to more proximate positionswhile inhibiting movement of the first and second sets of expandableelements to a more distant relative position along a length of the rail,after being moved to the more proximate position; (v) a threadedengagement feature for engaging the control wire; (vi) a seat region forengaging the push tube wherein the wire and the push tube engagerelatively movable elements and that upon relative motion can be made tobring the first and second set of expandable elements to their moreproximate position; (vii) a controllable stop element that inhibits thefirst set of expandable elements from extending beyond a desiredretention position when located in a first position and allows distalaxial collapse of the first set of expandable elements when located inanother position so that the instrument may be extracted in its entiretyfrom a proximal side of the tissue; (b) inserting a distal end of theinstrument through a proximal tissue region and then through a separateddistal tissue region; (c) expanding the first set of expandableelements; (d) locating the first set of expanded elements against a wallof the distal tissue region; (e) expanding the second set of expandableelements; (f) locating the second set of expanded elements against awall of the proximal tissue region; (g) relatively moving the first setof expanded elements and the second set of expanded elements toward oneanother to bring the proximal and distal tissue regions into a moreproximate position; and (h) releasing at least a portion of theinstrument from the catheter by rotating the control wire in a firstdirection so that a portion of the instrument that contains the firstand second sets of expanded elements remains in the body of the patientand retains the distal and proximal tissue regions in the more proximateposition, wherein the instrument is disengaged from the distal andproximal tissue regions by rotating the control wire in an oppositedirection to that of the first direction to allow collapse of the firstset of expandable elements in a distal direction as the instrument isextracted in a proximal direction.
 2. A surgical procedure forapproximating tissue within a patient's body, comprising: (a) locatingan approximation instrument within a body of a patient at an end of acatheter wherein the approximation instrument is functionally engagedwith a control wire and a push tube; the instrument comprising: (i) afirst set of expandable elements; (ii) a second set of expandableelements; (iii) a rail along which the first and second sets ofexpandable elements are located; and (iv) a locking mechanism forallowing the first and second sets of expandable elements to berelatively moved to more proximate positions while inhibiting movementof the first and second sets of expandable elements to a more distantrelative position along a length of the rail, after being moved to themore proximate position; (v) a threaded engagement feature for engagingthe control wire; (vi) a seat region for engaging the push tube whereinthe wire and the push tube engage relatively movable elements and thatupon relative motion can be made to bring the first and second set ofexpandable elements to their more proximate position; (vii) acontrollable stop element that inhibits the first set of expandableelements from extending beyond a desired retention position when locatedin a first position and allows distal axial collapse of the first set ofexpandable elements when located in another position so that theinstrument may be extracted in its entirety from a proximal side of thetissue; (b) inserting a distal end of the instrument through a proximaltissue region and then through a separated distal tissue region; (c)expanding the first set of expandable elements; (d) locating the firstset of expanded elements against a wall of the distal tissue region; (e)expanding the second set of expandable elements; (f) locating the secondset of expanded elements against a wall of the proximal tissue region;(g) relatively moving the first set of expanded elements and the secondset of expanded elements toward one another to bring the proximal anddistal tissue regions into a more proximate position; and (h) releasingat least a portion of the instrument from the catheter by rotating thecontrol wire in a first direction so that a portion of the instrumentthat contains the first and second sets of expanded elements remains inthe body of the patient and retains the distal and proximal tissueregions in the more proximate position wherein the control wire isrotatable relative to the engagement feature such that upon rotation inone direction the control wire is disengaged while rotation in anopposite direction causes turning of an oppositely threaded screw whichcauses movement of the stop to a second position.